Pursue a pivotal leadership career in pharmaceuticals by exploring Associate Director, Drug Product Manufacturing and Development (Oral) jobs. This senior role sits at the critical intersection of science, engineering, and business, focusing on transforming active pharmaceutical ingredients into safe, effective, and stable oral solid dosage forms like tablets and capsules. Professionals in this position are responsible for shepherding drug products from late-stage development through clinical trials and into commercial manufacturing, ensuring robust, scalable, and compliant processes. The core responsibilities of an Associate Director in this field are multifaceted. Typically, they provide technical leadership and oversight for formulation development, process optimization, and scale-up activities. A significant part of the role involves managing external partnerships, most commonly with Contract Development and Manufacturing Organizations (CDMOs). This includes selecting capable partners, drafting technical agreements, and providing on-site person-in-plant supervision during critical manufacturing campaigns for clinical or commercial supplies. Collaboration is essential, as the Associate Director works closely with cross-functional internal teams including Drug Substance, Analytical Development, Quality Assurance, Regulatory Affairs, and Supply Chain to align strategies and timelines. On a day-to-day basis, these leaders review and approve master batch records, analyze manufacturing data, and troubleshoot complex process issues. They play a key role in ensuring product quality and regulatory compliance by managing change controls, investigating deviations, and implementing corrective actions. A major strategic focus is on commercial preparedness, driving initiatives to enhance manufacturing efficiency, reduce costs, and ensure processes are robust and transferable to large-scale production facilities. Furthermore, they are instrumental in authoring and reviewing critical Chemistry, Manufacturing, and Controls (CMC) documentation for global regulatory submissions such as INDs, NDAs, and MAAs. Candidates seeking Associate Director, Drug Product Manufacturing and Development (Oral) jobs generally possess an advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related life science field, coupled with 10+ years of progressive experience in oral solid dosage form development and manufacturing. Expertise in unit operations like blending, granulation, compression, and film coating is mandatory. The role demands strong project management, negotiation, and communication skills for effective CDMO management. A deep understanding of cGMP regulations, quality systems, and regulatory filing requirements is critical. Success in these jobs requires a blend of technical prowess, strategic vision, and leadership ability to guide teams and projects from the lab to the patient, making it a highly impactful and sought-after profession in the biopharma industry.
